BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODIFIED CURVED THORACIC PROBE ASSEMBLY

    MDR report key: 3134020 · Received May 29, 2013

    Report

    Report Number
    1526439-2013-17748
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 6, 2013
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION FOUND BREAKAGE OCCURRED IN THE PROBE¿S DISTAL TIP. NO OTHER DEFECTS OR ABNORMALITIES WERE OBSERVED DURING EVALUATION OF PRODUCT. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE BEEN ATTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY REQUIREMENTS. REVIEW OF PRODUCT COMPLAINTS FOUND NO EMERGING TRENDS. ALTHOUGH NO DEFINITIVE CONCLUSIONS CAN BE MADE AS TO THE CAUSE OF TIP BREAKAGE, SCANNING ELECTRON MICROSCOPY ANALYSIS SHOWED EVIDENCE OF PLASTIC DEFORMATION AND ROUGH/GRAINY TEXTURE, INDICATING THAT THE PROBE UNDERWENT A STATIC BENDING FRACTURE FAILURE AT THE DISTAL TIP OF THE PROBE. THE EXISTENCE OF THE TWO SURFACE MORPHOLOGIES ILLUSTRATED THAT THE FRACTURE FIRST PROPAGATED AND THEN A FULL FAILURE/BREAKAGE TOOK PLACE, PRESUMABLY WHEN THE REMAINING REGION DID NOT HAVE STRENGTH TO BEAR THE LOAD. NO MATERIAL DEFECTS OR OTHER ABNORMALITIES WERE OBSERVED IN THIS ANALYSIS. IN THE ABSENCE OF AN IDENTIFIED DEVICE MANUFACTURING/RELEASE ISSUE OR OBSERVED TREND, THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED.

    Description of Event or Problem · 1

    THE CURVED PEDICLE PROBE BROKE DURING PREPARATION OF TRAJECTORY FOR AN EXPEDIUM POLYAXIAL SCREW. THE DISTAL END OF THE BROKEN PROBE MADE DEEP PENETRATION IN THE PEDICLE AND WAS DIFFICULT TO REMOVE. THE DIFFICULTY RESULTED IN A DELAY OF 15 MINUTES TO THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235627 MODIFIED CURVED THORACIC PROBE ASSEMBLY ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH DEPUY SYNTHES SPINE 0111N

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR